Friday, February 17, 2012

Qnexa safety

However, the FDA staff said patients taking the drug had more safety problems than patients on a placebo, including memory loss, and these problems could get worse over time.

(msnbc.com)

All three companies are in the process of resubmitting their products.

(CBS News)

U.S. regulators have cited concerns about the safety of Vivus' ($VVUS) experimental diet pill Qnexa in review documents as the California drug developer pursues the first FDA approval of a weight-loss drug in more than a decade.

(FierceBiotech)

The F.D.A. rejected the drug under review, Qnexa, in 2010, amid safety concerns, and the drugs manufacturer is now presenting additional data to argue its case.

(New York Times business news - Feb 17 - Reuters)

So far, its had a bumpy road to approval. Last year, the Food and Drug Administration (FDA) rejected Qnexa, citing safety concerns -- including elevated heart rate in some users and the potential for birth defects if pregnant women used the drug.

(PR Inside)

The FDA rejected the drug, Qnexa, in 2010 over safety concerns, but the drugs manufacturer is now presenting additional data to argue its case. But thousands of people across the country havent had to wait for the drugs approval.

(Austin American-Statesman)

For Qnexa, this is the second attempt by Vivus to gain approval as the FDA, citing safety concerns, rejected the drug in 2010. The market for obesity is huge, but Qnexa will have a very small slice of that pie, if it gets approval.

(Seekingalpha.com)

Contrave is one of three obesity drugs that the FDA has shot down over safety concerns, along with Arena Pharmaceuticals Incs lorcaserin and Vivus Incs Qnexa.

(Reuters)

The FDA asked Vivus, which is seeking approval of Qnexa, to remove from the obesity drugs proposed by the U.S.